The first non-radioactive device for tracking lymphatic nodes in patients with breast cancer has received premarket approval (PMA) from the FDA.

The Magtrace device is able to determine the most likely route that cancer cells will take after they spread from the primary tumour. Developed by surgical guidance company Endomag, the device is intended to help US hospitals reduce their reliance on radioactive tracers.

Treatment for cancer typically involves surgery to remove the tumour, followed by a lymphatic mapping procedure to assess if the cancer has spread to other parts of the body. This typically involves the use radioactive drugs and blue dyes which have limited availability and can cause pain and discomfort for patients.

Magtrace is a non-radioactive alternative that hopes to improve this process for both patients and surgeons. Intended to be used on breast cancer patients undergoing a mastectomy, Magtrace can be injected up to a week before surgery. The device’s tracer is small enough to move rapidly through the breast, yet big enough to be filtered by the first draining or ‘sentinel’ lymph nodes, the ones most likely to carry cancer. Using Magtrace in these nodes lets the surgeon accurately target them for removal, a critical step in determining the tumour stage and deciding on treatment going forward.

Principal investigator for the US Magtrace trial, professor Michael Alvarado, said: “We’ve been watching this technology become established in Europe over the past few years, and have been eagerly awaiting its availability in the US. During the SentimagIC trial I was impressed with how easy the technique was to learn, how intuitive the system was to use, and ultimately, as Principal Investigator for the trial, that our clinical outcomes matched the results that have been seen in the numerous European trials of Magtrace.

After 18 months of using the Sentimag platform with Magseed for lesion localisation, we’re really excited to add the sentinel node biopsy capability with Magtrace. Being able to carry out both seed localisation and sentinel node biopsy with one instrument, made this the only option for us. Magtrace and Magseed not only help to reduce the hospital staff and patients from exposure to radioactivity, they also offer us flexibility and so many more options when deciding on how to approach our breast cancer patients.”

Eric Mayes, CEO at Endomag, said: “This achievement demonstrates our team’s ability to innovate for the benefit of clinicians and their patients. The Sentimag platform is the first and only non-radioactive solution approved in the U.S. that can perform lesion localisation and sentinel node biopsy. The addition of Magtrace to the platform offers clinicians greater options and more flexibility when treating their patients and will help transform the way breast cancer is treated in the U.S.”